title: Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol.
abstract: BACKGROUND
  Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings.
  
  
  METHODS
  This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate).
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry (ANZCTR). Identifier: ACTRN12613000141741.
authors.affiliation: World Health Organization. betrana@who.int
authors.forename: Javier A
authors.initials: JA
authors.lastname: Schvartzman
authors.forename: Hugo
authors.initials: H
authors.lastname: Krupitzki
authors.forename: Ana Pilar
authors.initials: AP
authors.lastname: Betran
authors.forename: Jennifer
authors.initials: J
authors.lastname: Requejo
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bergel
authors.forename: Angel E
authors.initials: AE
authors.lastname: Fiorillo
authors.forename: Enrique C
authors.initials: EC
authors.lastname: Gadow
authors.forename: Francisco M
authors.initials: FM
authors.lastname: Vizcaino
authors.forename: Felicitas
authors.initials: F
authors.lastname: von Petery
authors.forename: Fernando
authors.initials: F
authors.lastname: Althabe
authors.forename: Jose
authors.initials: J
authors.lastname: Belizan
authors.forename: Franco
authors.initials: F
authors.lastname: Borruto
authors.forename: Michel
authors.initials: M
authors.lastname: Boulvain
authors.forename: Gian Carlo
authors.initials: GC
authors.lastname: Di Renzo
authors.forename: Metin
authors.initials: M
authors.lastname: Gülmezoglu
authors.forename: Justus
authors.initials: J
authors.lastname: Hofmeyr
authors.forename: Kevin
authors.initials: K
authors.lastname: Judge
authors.forename: Tak Yeung
authors.initials: TY
authors.lastname: Leung
authors.forename: My Huong
authors.initials: MH
authors.lastname: Nguyen
authors.forename: Ola Didrik
authors.initials: OD
authors.lastname: Saugstad
authors.forename: Marleen
authors.initials: M
authors.lastname: Temmerman
authors.forename: Alain
authors.initials: A
authors.lastname: Treisser
authors.forename: Effy
authors.initials: E
authors.lastname: Vayena
authors.forename: Mario
authors.initials: M
authors.lastname: Merialdi
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D011247:Pregnancy; D001118:Argentina; D017321:Clinical Trials, Phase I as Topic; D015331:Cohort Studies; D004869:Equipment Safety; D005113:Extraction, Obstetrical / Q000295:instrumentation / Q000379:methods; D005240:Feasibility Studies; D007743:Labor, Obstetric; D013525:Surgical Instruments; D015337:Multicenter Studies as Topic